Events

Retiro De Equipo (Recall) de Device Recall Encore and OneVue

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Coopervision Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    26532
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0978-03
  • Fecha de inicio del evento
    2003-06-25
  • Fecha de publicación del evento
    2003-07-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-04-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27846
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Lenses, Soft Contact, Daily Wear - Product Code LPL
  • Causa
    The actual sphere power of the lens is lower than the labeled value.
  • Acción
    Letters dated June 24, 2003 issued to eye care practitioners and distributors with instructions to return lenses to Coopervision. Distributors also instructed to notify their customers.

Device

Device Recall Encore and OneVue
  • Modelo / Serial
    There are 768 lot numbers as follows: 3669001157,  3669001465,  3669001756,  3669001960,  3669002711,  3669002714,  3669002816,  3669003208,  3669003214,  3669500011,  3669500414,  3669500514,  3779000756,  3779001722,  3779002117,  3779002513,  3779002911,  3779003020,  3779003624,  3779003906,  3779005316,  3779500013,  3779500120,  3890000722,  3890001706,  3891001712,  3892000954,  3892001402,  3892001414,  3892001712,  3893001417,  3893001611,  3893001711,  3893002612,  3893002613,  3893002712,  3893003020,  3893003107,  3893003302,  3893003614,  3893004706,  3893004806,  3893500111,  3893500702,  3893500802,  3893500902,  3894001058,  3894001560,  3894001654,  3894002213,  3894002607,  3894002610,  3894002811,  3894003005,  3894004306,  3894004502,  3894004904,  3894005004,  3894500205,  3894500310,  3894500311,  3894500313, 3894500402,  3894500411,  3894500511,  3894500704,  3894500706,  3895001456, 3895002758,  3895002855,  3895003024,  3895003220,  3895003315,  3895003320, 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  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Coopervision, Scottsville, NY is recalling from domestic customers nationwide. Product in Canada and Europe being recalled by affiliate in Europe.
  • Descripción del producto
    SOFT CONTACT LENSES (toric) packaged under the following labels: (1) CV \ ENCORE toric (methafilcon A) || and (2) ONEVUE 55 toric (methafilcon A) flexible wear. || Responsible firm on label: Coopervision, Hamble, SO31, 4RF, UK, Scottsville, NY 14546, USA *** Made in UK. The lenses are sold in boxes of 6 and sold individually as trial lenses.
  • Manufacturer
    Coopervision Inc

Manufacturer

Coopervision Inc
  • Dirección del fabricante
    Coopervision Inc, 711 North Road, Scottsville NY 14643
  • Source
    USFDA